Clinical Evidence

Explore clinical evidence, scientific presentations, and expert perspectives on the WiSE® System. This collection features pivotal study results, real-world clinical experience, and educational content that highlight the potential of leadless left ventricular endocardial pacing to address limitations of conventional CRT.

Scientific Presentations

Access expert presentations from EBR’s sponsored lunch symposium at Heart Rhythm 2026 (HRS 2026). Featuring leading electrophysiologists, these sessions highlight clinical evidence, patient selection considerations, case reviews, and early commercial experience with the WiSE System. Video recordings and presentation slides are available below for educational purposes.

This program is not part of Heart Rhythm 2026 as planned by the Heart Rhythm Program Committee. This event is neither sponsored nor endorsed by the Heart Rhythm Society. This event does not qualify for accredited continuing education (ACE) credit.

CBS Features First WiSE System Implant

Michael Chaves was born with a congenital heart defect, underwent heart surgery before his first birthday and received a pacemaker at the age of 17. As he grew older, he continued to experience shortness of breath and fatigue that made it difficult to keep up with everyday activities.

Earlier this year, Michael became the first adult congenital heart disease patient to receive the WiSE System. Dr. Haisam Ismali and the cardiac electrophysiology team at Northwell Health’s Long Island Jewish Medical Center implanted the leadless pacing system to work with Michael’s existing cardiac device and help synchronize his heartbeat.

Michael told CBS New York that he felt a difference immediately and has since been able to return to the gym without undergoing another open-heart surgery. His experience underscores the importance of continued innovation for patients with complex cardiac histories and limited treatment options.

We are grateful to Michael and his family for sharing their journey and to Dr. Ismali and the Northwell Health team for their clinical leadership and commitment to advancing patient care.

Watch the video and read Michael’s story from CBS New York: 1st"booster pack" pacemaker implanted in adult with congenital heart defect on Long Island - CBS New York

Note: Treatment decisions rest with the physician and care team based on individual patient anatomy and clinical need. Refer to the Instructions for Use for indications, contraindications, warnings, and precautions.

2022 Meta-analysis

A 2022 meta-analysis by Wijesuriya et al. consolidated findings from five pivotal studies conducted between 2014 and 2021. These studies collectively analyzed the outcomes of 175 HF patients who underwent the WiSE System implantation. Key findings include:

Improved echocardiographic response:

Average improvement in LVEF of 6.3% between baseline and 6-month follow-up across all 5 studies.

Improved NYHA classification:

Mean reduction of New York Heart Association (NYHA) class of 4.3 points.

Improved clinical response:

The pooled clinical response rate was 68% between baseline and 6-month follow-up.

High implant and procedural success:

Implant success rate was 96.6% with four studies reporting biventricular capture at six months in 90.6% of patients.

Limitations:

Non-randomized patients, small number of studies, heterogeneity of inclusions criteria, and a short follow-up duration of six months.

Conclusions and future directions:

Efficacy of leadless left ventricular endocardial pacing with the WiSE System was shown, supporting its use as a second-line therapy in patients in whom standard CRT has failed or is not possible.

*Wijesuriya N, Elliott MK, Mehta V, et al.Leadless left ventricular endocardial pacing for cardiac resynchronization therapy: A systematic review and meta-analysis. Heart Rhythm2022;19(7):1176-1183. DOI: 10.1016/j.hrthm.2022.02.018.

WiSE Clinical Program

Studies demonstrate on-going clinical impact of WiSE System, the leadless left ventricular endocardial pacing (LVEP) solution.

WiSE-CRT
SELECT-LV
Post-Market Surveillance Registry
SOLVE-CRT
Study Design
Single-arm, safety and feasibility
Single-arm, safety and efficacy
Real-world safety and performance
Single-arm, Roll-in
Pivotal: randomized and single-arm
# of Patients
13
34
153
31
183
# of Sites
11
7
19
68
Regions
EU
EU
EU, UK
AU, EU, UK, US

Publications

Clinical Study References